From Concept to Handover

Enhanced Conceptual Design
±30% cost estimation
  • Conceptual Design, optimization, detailed process description
  • Material and energy balance
  • Preliminary plant floor layout including equipment
  • Preliminary engineering of building and all services and engineering disciplines
  • Project Execution Plan
  • Preliminary project schedule
Employee Working on equipment
Feasibility
/preliminary studies
±20% cost estimation
Basic Engineering
±15% cost estimation
Detailed Engineering
±10% cost estimation
Project Controls
  • Cost Control
  • Integrated Master Schedule Control
  • Project Administration
Modular Facility Project
Management
Procurement support services
Execution Management
Linkedin Logo
© 2021 GMP Engineering
01
Process scope definition and  development
02
User Requirement Specification (URS)
03
Functional Requirement Specifications (FRS)
04
Design Specification
05
Process Flow Diagrams (PFD)
06
Piping & Instrumentation Diagrams (PID)
07
Equipment Specifications
08
BIM / 3D Piping Design & Isometrics
09
Computational Fluid Dynamics
10
Computer-aided Batch Process Simulation
11
Process optimization and scale-up Risk Assessments
12
Risk Assessments Hazard Identification (HAZID)
13
Hazard Identification (HAZID)
14
Hazard and Operability (HAZOP)
Linkedin Logo
© 2021 GMP Engineering

C&Q and Validation Services

Equipment Picture
Validation Master Plans (VMP) Cleaning Validation Approach
/Plans (CVA)
Process Validation
Approach
/Plans (PVA)
Cleaning and process validation protocol development and
execution
Auditing and Gap
Assessments
Computer System Validation

Commissioning
& Qualification

Protocol development
and execution of:

  • Design Qualification (DQ)
  • Factory Acceptance Testing (FAT)
  • Site Acceptance Testing (SAT)
  • Test Plan / Test Protocol
  • Requirements Traceability Matrix
  • Installation Qualification (IQ)
  • Operation Qualification (OQ)
  • Non product dependent
    performance qualification (nPdPQ)

Start Up

  • Equipment Training &
    Process Training
Equipment Picture 2

Compliance & Start Up

Regulatory compliance
Batch Production Record Development
GMP Consulting / Risk and Gap analysis
Compliance gap assessment
and audits
Quality management system development and implementation
Sterility and deviations investigations
Risk Assessment
GMP/GDP/GCP/GLP
Compliance Auditing
Standard Operating Procedures (SOPs) Development, Implementation & Optimization
Change Control and CAPA Process Optimizations
Compliance Investigations
Batch Records Review and Optimization
GMP Training
Supplier Qualification &
Auditing
Linkedin Logo
© 2021 GMP Engineering